Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis

NCT05944627 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: K0701
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients with Knee Osteoarthritis

Conditions

Knee Osteoarthritis

Keywords

FURESTEM-OA Kit Inj.; Knee Osteoarthritis Stem cell

Outcome Measures

Primary Outcomes (1)

• Assessment of safety and tolerability of FURESTEM-OA Kit Inj.

  Maximum Tolerated Dose (MTD) identification based on Dose Limiting Toxicities (DLTs) evaluation Evaluation of adverse events

  4 weeks follow-up after treatment

Secondary Outcomes (8)

• Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) score

  week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment

• Rate and amount of changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment

• Changes in 100 mm VAS score

  week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment

• Changes in the International Knee Documentation Committee Scoring System (IKDC) score

  week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment

• Evaluation of K&L grade

  week 24 after treatment

Study Arms (2)

FURESTEM-OA Kit Inj.

EXPERIMENTAL

Subjects are slowly administered FURESTEM-OA Kit Inj. once into the knee joint cavity contained in a disposable sterile syringe mixed with Solution 1 and Solution 2 depending on the dose group assigned at the baseline (Visit 2). The subjects are assigned sequentially to the following 3 dose groups in Phase 1 clinical trial, and in Phase 2a clinical trial, the subjects are randomized to 1-2 dose groups below MTD determined in Phase 1.

Biological: FURESTEM-OA Kit Inj.

Placebo

PLACEBO COMPARATOR

Product name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial)

Biological: Placebo

Interventions

FURESTEM-OA Kit Inj. BIOLOGICAL

FURESTEM-OA Kit Inj. is a combination medical product in which FURESTEM-OA Inj. (solution 1) is the primary mode of action and CAM Inj. (solution 2) acts as an auxiliary. The product is administered after mixing solution 1 and solution 2.

FURESTEM-OA Kit Inj.

Placebo BIOLOGICAL

placebo administration in Phase 2a clinical trial

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women over 19 years of age
• Those with a body mass index (BMI) of less than 30 kg/m2 at screening
• Those classified as ICRS grade 3 or 4 according to the International Cartilage Repair Society (ICRS) rating system through MRI examination at the time of screening
• Those diagnosed with knee osteoarthritis according to the diagnosis criteria of the American College of Rheumatology (ACR) at the time of screening
• Those diagnosed with Kellgren-Lawrence (K\&L) grade 2-3 knee osteoarthritis (OA) at the time of screening
• Those who do not have clinically significant abnormalities in the results of physical examination, hematologic test, blood chemistry test, or urine test
• Those whose symptoms (pain, etc.) do not improve despite conservative therapy (drug therapy, physical therapy, etc.) for at least 12 weeks
• Those with a 100 mm Visual Analogue Scale (VAS) score\* for pain at the time of screening of 50 mm or more
• Those who have heard and fully understood the detailed description of this clinical trial and have voluntarily decided to participate and agreed in writing to comply with the precautions

You may not qualify if:

• Those who have participated in at least one other clinical trial within 4 weeks before screening and received drugs (based on the last administration date), or received medical device treatment for clinical trials
• Those diagnosed with Kellgren-Lawrence (K\&L) grade 4 knee osteoarthritis (OA) at the time of screening
• At the time of screening, those with the results of the physical examination showing grade III (grade 0: none, grade I: 0\~5 mm, grade II: 5\~10 mm, grade III: \>10 mm) or more ligament instability
• Patients with osteochondritis dissecans
• Those with hypersensitivity reactions or allergies to components of the investigational product, FURESTEM-OA Kit Inj. (combination of (FURESTEM-OA Inj.)(solution 1) + (CAM Inj.)(solution 2))
• Those with the following confirmed medical history or surgical history / procedure history at the time of screening:
• Patients with a history of procedure or surgery (including arthroscopy) on the target knee within 24 weeks prior to the baseline visit (Visit 2)
• Patients who have undergone a knee joint replacement
• Those with any of the following diseases at the time of screening:
• Those with active infectious disease (hepatitis A/B/C (including carriers) or HIV infection that in the opinion of the investigator render those subjects as unfit to participate in this clinical trial. However, those who test positive by vaccination may participate.)
• Those who have been determined by the investigator as having difficulty participating in this clinical trial due to a severe chronic disease (cardiovascular disease, metabolic disease, renal dysfunction, etc., excluding controlled hypertension)
• Those with a skin disease or infection on the skin surface at the site where the investigational product is to be administered
• Those with severe pain in other areas that may affect the determination of symptoms in the knee joint (e.g., patients with poly-articular joint pain with severe osteoarthritis symptoms in other areas (such as the hip joint))
• Patients with other joint diseases, such as inflammatory joint diseases including rheumatoid arthritis, or infectious joint diseases such as septic arthritis, gout, recurrent pseudogout, joint fracture, acromegaly, Wilson's disease, primary osteochondrosis
• Patients with secondary osteoarthritis due to systemic diseases such as ochronosis or hemochromatosis

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kyoung-Ho Yoon, professor (CI)

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

• Sang Hak Lee, professor

  Gangdong Kyunghee University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Insun Baek

CONTACT

02-888-1590; isbaek@kangstem.com

Hyeseung Jeon

CONTACT

02-888-1590; hsjeon@kangstem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Phase 1 clinical trial was an open-label. Phase 2a clinical trial was conducted in a single-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: July 6, 2023
• Primary Completion: March 31, 2024
• Study Completion: February 28, 2026
• Last Updated: July 14, 2023

Record last verified: 2023-07